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Biomarkers in Patients at Risk of Developing Myelodysplastic Syndrome or Other Disorders and in Healthy Participants

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NHS Trust

Status

Unknown

Conditions

Leukemia
Myelodysplastic Syndromes

Treatments

Genetic: RNA analysis
Genetic: DNA methylation analysis
Genetic: polymerase chain reaction
Other: laboratory biomarker analysis
Genetic: cytogenetic analysis
Genetic: protein expression analysis
Genetic: gene expression analysis
Genetic: mutation analysis

Study type

Observational

Funder types

Other

Identifiers

NCT00899327
EU-20852
MRC-MDS-BIO1
CDR0000595855

Details and patient eligibility

About

RATIONALE: Studying samples of blood and bone marrow in the laboratory from patients at risk of developing myelodysplastic syndrome may help doctors learn more about changes that occur in DNA and identify biomarkers related to disorders of the blood and bone marrow.

PURPOSE: This research study is looking at biomarkers in patients at risk of developing myelodysplastic syndrome or other disorders and in healthy participants.

Full description

OBJECTIVES:

Primary

  • To identify novel biomarkers of disease that would help in the initial diagnosis of myelodysplastic syndromes (MDS).

Secondary

  • To understand the genesis of anemia in cancers.
  • To identify novel biomarkers of disease that predict progression of MDS to acute myeloid leukemia.

OUTLINE: Blood and bone marrow samples are collected. Hemopoietic stem cells (HSC) and progenitor cells are isolated from samples for analysis. Some of these HSC and progenitor cells are used for functional assays. From the rest of the cells, DNA, RNA, and protein is extracted for molecular analyses, including gene mutation analysis, gene methylation assays, chromatin immunoprecipitation, microarray, and real-time polymerase chain reaction.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

  • Must meet 1 of the following criteria:

    • Being investigated for a potential blood disorder due to abnormal blood count

    • Patients with a known blood disorder who are having a bone marrow sample taken as part of the assessment of that disorder

    • Patients undergoing hip replacement surgery at Nuffield Orthopaedic Centre, Oxford meeting the following criteria:

      • Not on treatment likely to impair bone marrow function
      • No history of having had treatment likely to have impaired bone marrow function
      • Normal blood count
    • Archived samples from patients with known blood disorder

PATIENT CHARACTERISTICS:

  • See Disease Characteristics

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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